Posted by Michael Wonder on 22 Oct 2018
CHMP recommends EU marketing authorisation of lanadelumab for the prevention of HAE attacks
19 October 2018 - f approved, lanadelumab would be the first monoclonal antibody for the preventive treatment of hereditary angioedema available in the European Union.
Shire announced today that the EMA's CHMP adopted a positive opinion recommending the granting of marketing authorisation of lanadelumab injection for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
The positive opinion is supported by data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study, the largest randomised controlled prevention study conducted to date in HAE, which evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in 125 patients 12 years of age or older with HAE.
